SurgiCase Planner SurgiCase Knee Planner

GUDID E314SURGICASEKNEEPLAN0

SurgiCase Knee Planner

Materialise NV

CAD/CAM software

• Primary Device ID: E314SURGICASEKNEEPLAN0
• NIH Device Record Key: 316ef4d7-a42e-4e9c-8938-015bbb96f3ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiCase Planner
• Version Model Number: SurgiCase Knee Planner
• Catalog Number: SurgiCase Knee Planner
• Company DUNS: 373139427
• Company Name: Materialise NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E314SURGICASEKNEEPLAN0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150928

FDA Product Code

• OOG: Knee Arthroplasty Implantation System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-19
• Device Publish Date: 2018-10-17

On-Brand Devices [SurgiCase Planner ]

• E314SURGICASESHOULPLAN0: SurgiCase Shoulder Planner
• E314SURGICASEPLANNER0: SurgiCase Planner
• E314SURGICASEKNEEPLAN0: SurgiCase Knee Planner